Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Myopia Clinical Trial

Official title:

Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708032
• Other study ID #: CR-0806
• Status: Completed
• Phase: N/A
• Start date: June 1, 2008
• Est. completion date: December 1, 2009

Study information

• Verified date: November 2019
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 1, 2009
• Est. primary completion date: December 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. = 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).

10. They have diabetes.

11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• spectacles
habitual spectacles
• narafilcon A soft contact lenses
narafilcon A daily disposable contact lenses

Locations

Country	Name	City	State
United Kingdom	Eurolens Research, The University of Manchester	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Papillary Conjunctivitis	Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.	12 months
Secondary	Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.	Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.	at 12 months
Secondary	Visual Acuity After 12 Months of Wear	Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.	at 12 months
Secondary	Subjective Overall Comfort After 12 Months of Daily Wear	subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort	at 12 months
Secondary	Subjective Overall Vision After 12 Months of Daily Wear	subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision	at 12 months